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510(k) Data Aggregation

    K Number
    K250001
    Device Name
    Patriot SI Implant System
    Manufacturer
    Spinal Simplicity LLC
    Date Cleared
    2025-06-03

    (152 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K232259
    Why did this record match?
    Device Name :

    Patriot SI Implant System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

    Device Description

    The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the Patriot SI Implant System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for the purposes of an AI/software device.

    The document is for a physical medical implant device (sacroiliac joint fusion implant). The information it provides is:

    • Device Type: Patriot SI Implant System (a physical implantable device)
    • Intended Use: Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    • Materials: Additively manufactured titanium alloy, Ti-6Al-4V-ELI, with or without hydroxyapatite (HA) coating.
    • Testing Information: "Non-clinical cadaveric biomechanical testing was performed to support substantial equivalence of the Patriot SI Implant system." This type of testing is relevant for mechanical implants, not AI/software.
    • Predicate Device: Patriot-SI Posterior Implant System (K232259).

    Therefore, I cannot provide details on acceptance criteria and study design for an AI/software device based on this document. The questions posed in your request (sample size, expert qualifications, MRMC studies, standalone performance, ground truth types) are universally applicable to AI/software performance studies, but the source document is entirely about a physical hardware device.

    If you have a document describing an AI/software medical device, I would be happy to analyze it according to your criteria.

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